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Standards [CURRENT]

ISO 22442-3

Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
Edition 2007-12

Medical devices utilizing animal tissues and their derivatives - Part 1: application of risk management
Edition 2020-12-09

Standards [CURRENT]

ISO 19090

Tissue-engineered medical products - Bioactive ceramics - Method to measure cell migration in porous materials
Edition 2018-01

Medical devices - Quality management systems - Requirements for regulatory purposes
Edition 2021-09-08

Regulation

EUV 2023/2482

Commission Regulation (EU) 2023/2482 of 13 November 2023 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards the substance bis(2-ethylhexyl) phthalate (DEHP) in medical devices
Edition 2023-11-13

Biological evaluation of medical devices - Part 15: identification and quantification of degradation products from metals and alloys
Edition 2023-05-24

Standards [CURRENT]

ISO 22610

Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration
Edition 2018-09

Standards [CURRENT]

BS EN ISO 13408-7

Aseptic processing of health care products. Alternative processes for medical devices and combination products
Edition 2013-02-28

Pre-standard

ISO/TS 21560

General requirements of tissue-engineered medical products
Edition 2020-08

Standards [CURRENT]

ISO 13485

Medical devices - Quality management systems - Requirements for regulatory purposes
Edition 2016-03

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